Pinless-Navigated Versus Conventional Total Knee Arthroplasty

Radiographic Analysis Comparing Pinless-Navigated and Conventional Total Knee Arthroplasty: A Randomized Controlled Trial

The success of total knee arthroplasty depends on a number of factors including pre-operative range of movement, obesity, medical comorbidities, prosthesis design, preparation and implantation of the prosthesis, soft tissue balancing, as well as implants alignment. Optimal placement of the implants within 3° of the mechanical axis of the lower limb has been proven to reduce wear and early implant failure.

Compared to conventional techniques, computer-Aided Navigation total knee arthroplasty has been widely used in the last decade and have been proven to improve the accuracy of prosthesis placement and lower limb alignment by reducing the number of outliers with more than 3° deviation from the mechanical axis. However, its use also involves a steep learning curve, high initial capital cost and longer duration of surgery.

Traditional computer-navigated TKA using optical tracking systems also requires fixation of the femoral and tibial reference arrays to bone using anchoring pins. Complications reported with the use of these pins include either femoral or tibial fracture, pin site pain, pin site infection and osteomyelitis. The investigators study aims to investigate the accuracy of a new pinless navigation system for TKA that will avoid these complications.

Study Overview

• Status: Completed
• Conditions: Arthropathy of Knee
• Intervention / Treatment: Procedure: Pinless-Navigated Total Knee Arthroplasty; Procedure: Conventional Total Knee Arthroplasty

Detailed Description

The duration of surgery and length of hospital stay were recorded for all patients. Three radiographic measurements were recorded on the coronal films: 1) Hip-Knee-Ankle Angle (HKA), the angle formed by the mechanical axis of the femur (line between the centre of the femoral head and the centre of the knee) and the mechanical axis of the tibia (line between the centre of the talus and the centre of the knee); 2) Coronal Femoral-Component Angle (CFA), the angle formed by the femoral component and the mechanical axis of the femur; 3) Coronal Tibia-Component Angle (CTA), the angle formed by the tibia base plate and the mechanical axis of the tibia. The post-operative radiographic measurements were compared with the intra-operative readings from the pinless navigation system. The accepted values used in our study for normal alignment were: 1) 0° ± 3° varus/valgus for HKA; 2) perpendicular (± 3°) to the mechanical axis of the femur; 3) perpendicular (± 3°) to the mechanical axis of the tibia.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients between the ages of 45 and 90 diagnosed with osteoarthritis of the knee and scheduled for unilateral total knee replacement.

Exclusion Criteria:

• Patients coming for revision total knee arthroplasty
• Patients diagnosed with inflammatory arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Pinless-Navigated Total Knee Arthroplasty; The patients underwent total knee arthroplasty using a Pinless-Navigated system that is designed to restore the mechanical alignment of the lower limb.	Procedure: Pinless-Navigated Total Knee Arthroplasty; Brainlab VectorVision Knee 2.5 Navigation System
ACTIVE_COMPARATOR: Conventional Total Knee Arthroplasty; The patients underwent total knee arthroplasty using conventional technique.	Procedure: Conventional Total Knee Arthroplasty; Conventional technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic analysis	The number of outliers and mean value of: 1) Hip-Knee-Ankle Angle (HKA), the angle formed by the mechanical axis of the femur (line between the centre of the femoral head and the centre of the knee) and the mechanical axis of the tibia (line between the centre of the talus and the centre of the knee); 2) Coronal Femoral-Component Angle (CFA), the angle formed by the femoral component and the mechanical axis of the femur; 3) Coronal Tibia-Component Angle (CTA), the angle formed by the tibia base plate and the mechanical axis of the tibia.	Up till 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgery	Comparing the mean duration of surgery for both surgical arms.	Up till 1 year

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Investigators: Principal Investigator: Pak Lin Chin, FRCS, Singapore General Hospital

Publications and helpful links

Helpful Links

• Singapore General Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (ESTIMATE): August 30, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Total Knee Replacement, Computer-Assisted Surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2011/519/D